DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot number 078T1141
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Encore Medical, LP
Reason for Recall:
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Product Codes/Lot Numbers:

Lot number 078T1141

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1257-2022

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Jan 5, 2026 Implants & Prosthetics View Details →